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Compares treatment options for Maintenance Treatment of Peripheral T-cell Lymphoma
Official title Golidocitinib Versus Placebo as Maintenance Therapy for Peripheral T-Cell Lymphoma
ClinicalTrials.gov ID: NCT07300514
What this study is testing
What is golidocitinib?
golidocitinib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for maintenance treatment of peripheral t-cell lymphoma.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a multicenter, randomized, double-blind, placebo-controlled phase III trial evaluating golidocitinib as maintenance therapy in adult patients with peripheral T-cell lymphoma (PTCL) who achieved complete response (CR) or partial response (PR) after first-line systemic chemotherapy and are not candidates for hematopoietic stem cell transplantation (HSCT) or decline HSCT. Eligible patients with histologically confirmed PTCL subtypes (PTCL-NOS, ALK-positive anaplastic large cell lymphoma [ALK-ALCL], angioimmunoblastic T-cell lymphoma [AITL], or follicular helper T-cell phenotype PTCL [FTCL/PTCL-TFH]) according to the 2016 WHO classification will be randomized 1:1 to receive oral golidocitinib or matching placebo.
- Phase 3: a large, late-stage study
- Time commitment: about 2 years
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Signed written informed consent prior to any study-specific procedures and willingness to comply with all study requirements.
- Age ≥18 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 without deterioration within 2 weeks before screening.
- Histologically confirmed PTCL according to the 2016 WHO classification, limited to the following subtypes: PTCL-not otherwise specified (excluding...
- Achieved complete response (CR) or partial response (PR) after first-line systemic standard chemotherapy with CHOP, BV-CHP, or CHOP-like regimens, as...
You likely can't join if
- Ann Arbor stage I disease at initial diagnosis.
- Prior treatments that could interfere with study therapy, including but not limited to:
- Investigational agents or antineoplastic drugs within 30 days before first study dose.
- Cytotoxic chemotherapy within 21 days before first study dose.
- Systemic corticosteroids at a prednisone-equivalent dose \>10 mg/day within 7 days before first study dose.
- Major surgery (excluding vascular access procedures) or severe trauma within 4 weeks before first study dose, or planned surgery during study...
See the full eligibility criteria
- Signed written informed consent prior to any study-specific procedures and willingness to comply with all study requirements.
- Age ≥18 years at the time of informed consent.
- Eastern Cooperative Oncology Group (ECOG) performance status 0-1 without deterioration within 2 weeks before screening.
- Histologically confirmed PTCL according to the 2016 WHO classification, limited to the following subtypes: PTCL-not otherwise specified (excluding primary cutaneous PTCL), ALK-positive anaplastic large cell lymphoma...
- Achieved complete response (CR) or partial response (PR) after first-line systemic standard chemotherapy with CHOP, BV-CHP, or CHOP-like regimens, as assessed by Lugano 2014 criteria; patients must be ineligible for...
- Adequate bone marrow and organ function, including:
- Absolute neutrophil count (ANC) ≥1.5×10⁹/L (≥1.0×10⁹/L if bone marrow is involved by lymphoma), without use of colony-stimulating factors within 7 days before study entry.
- Platelet count ≥100×10⁹/L (≥75×10⁹/L if bone marrow is involved by lymphoma), without transfusion or platelet growth factors within 7 days before study entry.
- Hemoglobin ≥10 g/dL.
- Total bilirubin ≤2× upper limit of normal (ULN).
- ALT and AST ≤2.5×ULN.
- Serum creatinine ≤1.5×ULN or creatinine clearance ≥50 mL/min (calculated or measured).
- Left ventricular ejection fraction (LVEF) ≥50% on echocardiography.
- Willingness and ability to comply with study procedures and follow-up.
- Ann Arbor stage I disease at initial diagnosis.
- Prior treatments that could interfere with study therapy, including but not limited to:
- Investigational agents or antineoplastic drugs within 30 days before first study dose.
- Cytotoxic chemotherapy within 21 days before first study dose.
- Systemic corticosteroids at a prednisone-equivalent dose \>10 mg/day within 7 days before first study dose.
- Major surgery (excluding vascular access procedures) or severe trauma within 4 weeks before first study dose, or planned surgery during study treatment.
- Antineoplastic monoclonal antibodies (including brentuximab vedotin) within 4 weeks before first study dose; radiotherapy within 3 weeks; other toxin- or radioisotope-conjugated antibodies within 10 weeks.
- Prior treatment with any JAK or STAT3 inhibitor.
- Antitumor immunotherapy (e.g., immune checkpoint inhibitors including PD-1, PD-L1, CTLA-4 antibodies) within 28 days before first study dose.
- Live attenuated or viral vector vaccines within 28 days before first study dose.
- Current use of vitamin K antagonists, antiplatelet or anticoagulant drugs that cannot be discontinued ≥7 days before first study dose.
- Concomitant medications that are strong CYP3A inducers or inhibitors, or BCRP/P-gp substrates with narrow therapeutic index that cannot be stopped ≥7 days before first study dose, as specified in the protocol appendix.
- Active hepatitis C infection (positive anti-HCV antibody).
- Hepatitis B virus (HBV) DNA ≥1000 IU/mL or other HBV status not meeting protocol-defined criteria for safe inclusion.
- Known HIV infection with confirmed positive serology.
- Any uncontrolled, clinically significant comorbidities or laboratory abnormalities that, in the investigator's judgment, would increase risk or interfere with study participation.
- History of drug-induced interstitial lung disease or current evidence of clinically significant interstitial lung disease.
- Pregnant or breastfeeding women; women of childbearing potential and men with fertile partners who are unwilling or unable to use effective contraception during treatment and for the protocol-specified period after the...
The study team makes the final eligibility decision.
Where it's taking place
- Shanghai, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 2 years per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Shanghai, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.